Clinical trial secukinumab lupus nephritis | Novartis United States of America

Trial Purpose

To demonstrate the efficacy, safety, and tolerability of secukinumab compared to placebo in participants with active lupus nephritis (LN) who are also receiving standard of care therapy at week 52. To evaluate long-term efficacy, safety, and tolerability, data will be collected for up to 2 years.

Diagram of a kidney — Diagram of Kidney Function

Novartis is launching a research study to find out if treatment with secukinumab combined with standard of care therapy is safe, and if this combination of treatments can block or reduce immune system attacks on the kidneys in patients with LN. This study is a placebo-controlled, phase 3, interventional clinical trial.

If you are interested in joining this clinical trial, please contact the Novartis US Medical Information Call Center at (+1 888-669-6682) for more information.

About Lupus Nephritis

Lupus nephritis (LN) is the medical term for kidney inflammation and irritation caused by lupus. Lupus is an autoimmune disease, which causes your immune system to attack your body’s healthy cells, tissues, and organs. When your immune system attacks your kidneys, they can become damaged and unable to remove waste from your blood or control the amount of fluids in your body.

Not everyone with lupus is diagnosed with LN, but around 50% of people who have lupus go on to develop LN. LN may get worse over time and could lead to kidney failure.

There is no cure for lupus or LN, however most people diagnosed with the disease are prescribed a combination of different medications to help manage their symptoms, improve their quality of life, and reduce the risk of more serious complications. The combination of medications currently used to manage LN symptoms is called standard of care therapy, which is a formal set of treatment guidelines for the management of LN that have been developed by the American College of Rheumatology, and widely accepted by physicians who treat patients with LN. A class of medications called immunosuppressants are used as the current standard of care in LN. Steroids, such as prednisolone, belong to this class of medications belong to this class of medications. However, some patients with LN do not respond to standard of care therapy.

If you have lupus and are experiencing new or worsening symptoms of LN, such as high blood pressure, foamy or frothy urine, or swelling of the legs, ankles, or feet, participating in this trial may provide relief from your symptoms and potentially improve your quality of life.

If you are interested in joining this clinical trial, please contact the Novartis US Medical Information Call Center for more information at:

+1 888-669-6682

Why Should I Participate in This Clinical Trial?

If living with LN is disrupting your everyday life, Novartis invites you to see if you qualify for a new study that may help reduce your LN symptoms. This trial has been designed with hopes of developing a medication that may:

Improve response to treatment in patients with LN who have not previously responded to standard of care therapy alone
Increase the length of time patients with LN can experience complete or partial reversal of their LN symptoms
Reduce the use of steroids and other immunosuppressant medications in LN, thereby decreasing the occurrence of side effects associated with their use, including increased risk of infection
Potentially improve quality of life for patients with LN

If you have active LN and have been treated or are willing to be treated with standard of care therapy, we encourage you to see if you qualify to participate in this study. We are seeking 460 participants globally, 69 in the United States.

To learn more about participating in a clinical trial, watch our video below:

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Healthcare professional talking to a patient

About This Clinical Trial

Novartis is launching a research study to find out if treatment with secukinumab combined with standard of care therapy is safe, and if this combination of treatments can block or reduce immune system attacks on the kidneys in patients with LN. This study is a placebo-controlled, phase 3, interventional clinical trial.
Placebo-controlled is a term used to describe a method of research in which an inactive substance (a placebo) is given to one group of participants, while the medication being tested is given to another group.
Interventional means that participants will receive one or more medications or treatments over the course of their participation in the study.

Secukinumab blocks a molecule called interleukin-17A (IL-17A), which is believed to play an important role in inflammation.

Secukinumab the medication being evaluated in this trial, is administered by subcutaneous (s.c.) injection. An s.c. injection is the method used to administer medication under the skin.

Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis (SELUNE)

Reference NR & CT.gov identifier: NCT04181762

To better understand some of the words and key terms included in this information, please watch the Definitions Video from our Understanding Clinical Trials series.

Trial Summary

Condition – Lupus nephritis

Study Phase – 3

Study Type – Interventional

Genders – All

Ages – 18-75 (Adult, Older Adult)

Accepts Healthy Volunteers – No

Actual Start Date – July 8, 2020

Estimated Primary Completion Date – January 25, 2025

Estimated Study Completion – January 9, 2026

Estimated Enrollment – 460 participants, 69 in the United States

Recruitment Status – Recruiting

Watch our definitions video to better understand the key words used in clinical trials.

If you are interested in joining this clinical trial, please contact the Novartis US Medical Information Call Center for more information at:

+1 888-669-6682

Frequently asked questions

If you think you may qualify for this study, please click here. A study representative may contact you and connect you with an investigational trial site near you, where a further assessment will be performed. We encourage you to continue to work with your doctor to find ways to address, treat, and manage your lupus nephritis.

The researchers will evaluate the study medication’s effectiveness vs a placebo when combined with standard of care therapy. You will be randomly assigned to 1 of 2 groups, which will determine the type of treatment you will receive:

Group 1 will be treated with 300 mg of s.c. secukinumab once a week for 4 weeks, followed by 300 mg s.c. secukinumab every 4 weeks through week 100
Group 2 will be treated with s.c. placebo once a week for 4 weeks, followed by s.c. placebo every 4 weeks through week 100
All participants will receive standard of care therapy

The study will last 2 years and consists of 4 parts:

Screening period: Up to 6 weeks
Run-in period (optional): Up to 4 weeks before the first treatment visit (the investigator will decide if this period is necessary for some participants who are not already taking standard of care therapy)
Treatment period: Total duration of 104 weeks
Follow-up period: Total duration of 8 weeks after the last treatment visit

All study-related care is provided at no cost. You may discontinue participation at any time.

If you wish to participate in the trial, you must meet the following main requirements:

Male and female participants must be between 18 and 75 years of age
Female participants must not be pregnant or lactating
Have a confirmed diagnosis of systemic lupus erythematosus and/or lupus nephritis
Have a confirmed diagnosis of active lupus nephritis
Currently taking or willing to take standard of care therapy, such as immunosuppressants and steroids
Must not have severe kidney disease

Your doctor can also help you determine if you qualify by performing the required diagnostic tests. To view a complete list of inclusion and exclusion criteria, please click here.

Drug: Secukinumab plus standard of care therapy

or

Drug: Placebo plus standard of care therapy

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Explore an Investigative Study Treatment for Lupus Nephritis

Trial Purpose

About Lupus Nephritis

Why Should I Participate in This Clinical Trial?

About This Clinical Trial

Trial Summary